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Donor sperm and ova inspections

Inspection report card summary

Initial inspection deficiencies report
Establishment name Reference number Inspection start date Inspection type Inspection rating
NewLife Fertility Centre 0747EA7D 2024-05-27 Re-Inspection Compliant

Summary of observations

Observation number Regulation Summary of observation
136- Directed Donation Process
  • The summary document confirming the directed donation did not always include all required information.
  • The primary establishment did not always ensure that the medical director created or signed a summary document for directed donations.
238- Directed Donation Process
  • In the context of a directed donation, the establishment did not quarantine sperm or ova until the medical director of the primary establishment responsible for the quarantine determined and documented that sperm and ova can be released from quarantine.
343- Quality Management System
  • The establishment’s document control or records management system was not sufficient.
  • Some standard operating procedures were not always followed.
444- Quality Management System
  • Some processes were not described in standard operating procedures.
  • Some standard operating procedures were not kept up to date.
550- Labelling and Storing
  • The primary establishment did not always ensure that the immediate container of sperm or ova was labelled in accordance with the requirements of the Regulations before distributing or making use of the sperm or ova.
653- Personnel, Facilities, Equipment and Supplies
  • The establishment’s program for the initial and ongoing training of all personnel and for evaluating their competency was not sufficient.
757- Personnel, Facilities, Equipment and Supplies
  • The establishment did not ensure that some critical equipment was validated, calibrated, cleaned or maintained as required.
884- Records
  • The establishment’s records were not always accurate, complete, legible and/or indelible.

Inspection outcome

The inspection resulted in a compliant rating. The establishment was compliant with the Safety of Sperm and Ova Regulations.

The rating is the result of observations made by Health Canada based on a reasonable belief at a particular point in time during the course of an inspection that the establishment was conducting the regulated activities in compliance with the Safety of Sperm and Ova Regulations.

Measures taken by Health Canada

  • We requested corrective actions.
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